Key Points
- The first patient has been treated in a clinical trial at the University of Virginia exploring focused ultrasound-induced immune responses.
- Researchers will assess the effect of focused ultrasound plus a chemotherapy drug on patients with early-stage breast cancer.
- This trial is being supported in part by the Focused Ultrasound Foundation and the Commonwealth of Virginia.
The first patient has been treated in a clinical trial exploring focused ultrasound-induced immune responses of patients with breast cancer at the University of Virginia (UVA Health).
The 48-patient clinical trial is assessing the effect of using Theraclion’s EchoPulse focused ultrasound device plus a chemotherapy drug on patients with early-stage breast cancer. The study consists of three arms: one participant cohort will receive only focused ultrasound to ablate – or destroy – part of the tumor, another cohort will be given a low dose of the common chemotherapy drug gemcitabine, and the final cohort will receive gemcitabine followed by a focused ultrasound ablation procedure approximately one week later.
As patients complete the protocol for their arm of the trial, they will undergo surgery to remove the tumor. Researchers will assess the participants’ immune response to each of the three regimens as well as post-trial surgery outcomes.
Preclinical studies have suggested that focused ultrasound can “unmask” breast cancer cells, making them visible to the immune system. Additionally, gemcitabine is known to inhibit cells that suppress the immune response. Thus, when used in combination, focused ultrasound and gemcitabine enhance the anti-cancer immune response by promoting activation of immune cells and downregulating immune suppressor cells.
The trial is being led by Patrick Dillon, MD, Associate Professor at UVA Health’s Division of Hematology/Oncology, and David Brenin, MD, FACS, Associate Professor of Surgery and Chief of Breast Surgery.
“We will examine whether, in the cohort of patients that receive focused ultrasound and gemcitabine, we see a two-fold immune response where there is a decrease in the cells that suppress the immune system and an increase in T cell activity,” said Dr. Dillon. “We are also focused on ensuring that the study does not delay or hinder surgical removal of the tumor, because that is still an effective standard-of-care for these patients.”
This trial is being supported in part by the Focused Ultrasound Foundation and the Commonwealth of Virginia.
“The Foundation recognizes that the intersection of focused ultrasound therapy and cancer immunotherapy offers a highly promising opportunity for combination approaches to treat a variety of cancers,” said Foundation Chairman Neal F. Kassell, MD. “The clinical team at UVA is leading the charge in advancing this important field.”
This trial will build upon a previous immunotherapy clinical trial at UVA Health that explored the immune response of focused ultrasound plus a chemotherapy drug in patients with metastatic breast cancer.
For more information about this trial, please click here.